# The contribution of contrast media exposure to acute kidney injury in patients evaluated for pulmonary embolism in the emergency care setting: a prospective, randomized trial

> **NIH NIH R01** · INDIANA UNIVERSITY INDIANAPOLIS · 2020 · $656,709

## Abstract

PROJECT ABSTRACT
For over 4 decades, studies identify Contrast-Induced Nephropathy (CIN) as a leading cause of acute kidney
injury (AKI). Following exponential increases in CT imaging, exposures to contrast media are a major public
health problem, especially in the emergency care setting: >10% of patients with chest symptoms undergo
CT of the pulmonary arteries (CTPA) for suspected pulmonary embolism (PE). However, recent studies
question whether contrast media exposure actually contributes to overall AKI-risk, even in patients with renal
dysfunction. Without prospective validation of either conclusion, physicians are unable to accurately identify
high risk patients and are left with current practices that delay or forgo contrast-enhanced imaging, but may
not actually reduce AKI-risk. Preliminary data from the PI underscores the significance of the problem
perpetuated by this knowledge gap: 1) >15% of patients develop AKI after CTPA; 2) AKI is associated with
a 2-fold increase in the risk of subsequent death, renal failure and major cardiovascular events; and 3) Serum
creatinine screening (and GFR estimation) has unacceptable sensitivity (13%) in the heterogeneous
emergency care setting. In response, the applicant derived a clinical decision rule, the AKIrisk Score. The
long-term goal is to identify causes of (such as CIN), and, ultimately, prevent AKI in the emergency care
setting. The immediate objectives are to 1) Validate risk-stratification methods in the emergency care setting
and 2) Test if contrast media exposure, as a result of CTPA for PE, increases the risk of AKI and subsequent
severe outcomes. The central hypothesis is that while a clinical decision rule more accurately risk-stratifies
patients for AKI than serum creatinine screening, subsequent avoidance of exposure to contemporary
contrast media agents does NOT alter overall AKI-risk, and will be tested by three specific aims: 1) Determine
if an AKIrisk score <2 points predicts <10% AKI; 2) Test if cystatin-C and/or NGAL improve AKIrisk score
accuracy; and 3) Compare the incidence of AKI and long-term outcomes in 600 patients with an AKIrisk
score ≥2 points, randomized to CTPA (contrast media exposure) or ventilation scintigraphy (VQ, unexposed
control). The first aim will validate the AKIrisk score, which has previously demonstrated improved accuracy
over serum creatinine screening in a large prospective cohort (633 patients). The second aim will also
validate the applicant’s prior work demonstrating the additional benefit of acute-phase biomarkers of renal
dysfunction. In the third aim, patients will be randomized to contrast media exposure with one of two
standard-of-care PE imaging studies and followed for AKI and long-term outcomes. This innovative approach
departs from serum creatinine screening, which is outdated and ineffective in the undifferentiated, acutely ill
population characteristic of the emergency care setting, and is the first truly feasible trial of AKI-risk that...

## Key facts

- **NIH application ID:** 9870959
- **Project number:** 5R01HL132358-04
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** Alice Marina Mitchell
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $656,709
- **Award type:** 5
- **Project period:** 2017-04-06 → 2024-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9870959

## Citation

> US National Institutes of Health, RePORTER application 9870959, The contribution of contrast media exposure to acute kidney injury in patients evaluated for pulmonary embolism in the emergency care setting: a prospective, randomized trial (5R01HL132358-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9870959. Licensed CC0.

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